Replies to post #134914 on Biotech Values

[BTH]

In truth, he will be disappointed if this should happen

Yeah that was a pretty JV thing to say.

[jbog]

The recently updated the data from Onty's original PhII trial actually showed some impressive results, But in that trial and the Current trial those aren't the endpoints they picked.....

J Cancer Res Clin Oncol (2011) 137:1337–1342

Purpose To present an updated survival analysis of an open-label, parallel-group, phase IIB trial of BLP25 liposome vaccine (L-BLP25) in patients with stage IIIB or IV non-small-cell lung cancer (NSCLC).

Methods Patients were randomized to either L-BLP25 plus best supportive care (BSC) or BSC alone. Patients in the L-BLP25 arm received subcutaneous vaccinations of L-BLP25 930 lg weekly for 8 weeks, followed by maintenance vaccinations at 6-week intervals.

Results Median survival time was 4.2 months longer in patients receiving L-BLP25 plus BSC (n = 88) than in those receiving BSC alone (n = 83; 17.2 months vs. 13.0 months, respectively; hazard ratio [HR] 0.745, 95% confidence interval [CI] 0.533–1.042). The 3-year survival rate was 31% in patients receiving L-BLP25 plus BSC and 17% in those receiving BSC (P = 0.035).

In the stratified subset of patients with stage IIIB loco-regional (LR) disease (this is the new trial design), median survival time was 17.3 months longer in patients receiving L-BLP25 plus BSC (n = 35) than in those receiving BSC (n = 30; 30.6 months vs. 13.3 months, respectively; HR 0.548, 95% CI 0.301–0.999). In this subgroup, 3-year survival was 49% in patients receiving L-BLP25 plus BSC and 27% in those receiving BSC (P = 0.070). (decent considering the subset size)

Conclusions Confirming the initial results, further followup continues to show that survival time for patients with stage IIIB/IV NSCLC was longer with L-BLP25 plus BSC compared with BSC alone, with the greatest difference seen in patients with stage IIIB LR disease.

[acgood]

ONTY-

the very same interview broke another rule - he said that the delay in trial read out is probably a good thing - ""In some sense, the longer it takes the better it is" .... Plus the phase 3 trial is built off a subset analysis of a phase 2b that did not achieve it's primary endpoint

all in all surprised this one won a spot in even your charity portfolio

And a bonus quote re their PI3K program..."hopefully some competitors' will fail and the partners will come to us then"

[mcbio]

White lie from ONTY’s CEO:

www.reuters.com/article/2012/01/11/us-healthcare-oncothyreon-idUSTRE80A24F20120111
Quote:
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“We would be perfectly content if the decision is to continue the [Stimuvax] trial to its end,” Kirkman said.
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In truth, he will be disappointed if this should happen. Failure of Stimuvax to hit the success threshold in the second interim analysis would further narrow the window for the best-case scenario in which Stimuvax shows extraordinarily strong efficacy.

Yeah, that's a bit of a silly statement.

[iwfal]

ONTY -

In truth, he [Kirkman - the CEO] will be disappointed if this should happen. Failure of Stimuvax to hit the success threshold in the second interim analysis would further narrow the window for the best-case scenario in which Stimuvax shows extraordinarily strong efficacy.

In the same interview he also prognosticated that if this interim was a bust that they would get to the final before the end of the year. Fat chance of this given that to get from 50% event fraction to 75% event fraction is taking >15 months or so.

Couldn't ask for clearer proof that many small biotechs really haven't a clue when it comes to clinical trial design/prediction - e.g. typically not accounting for either:

a) What the end of enrollment does to an event rate driven by an exponential curve.

b) The general slowing of events as the tail of the curve comes into play.

PS I wouldn't label this a 'white lie' even if I had picked it in the Charity Contest -g-

PPS Speaking of charity contest, I coin flipped ACHN or IDIX. Bummed I went against the advice of a guru I consulted (who suggested IDIX as the better play)